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Diabetic Macular EdemaPhase 2/3DAMNCT03143192

Treatment of Diabetic Macular Edema With Aflibercept and Micropulse Laser

A Phase 2/3 study testing Micropulse Laser in people with Diabetic Macular Edema, run by Keyvan Koushan at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of centre-involved diabetic macular edema. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Micropulse Laser
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
2 sitesCanada
Study dates
8 Mar 2017to 9 May 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Type I or Type II Diabetes Mellitus
  • Presence of centre-involved Diabetic Macular Edema (DME) with the Central Macular Thickness (CMT) of ≥ 310µm on the spectral-domain Optical Coherence Tomography (OCT)
  • Best corrected Visual Acuity (BCVA) between, and including, 20/30 and 20/400 in the study eye.
  • Patient's willingness and ability to attend the study visits

Who cannot join

  • Any other potential causes of macular edema such as active uveitis, epiretinal membrane, post-operative CME, and vitromacular traction
  • Any history of major intraocular surgery (such as cataract surgery or vitrectomy) in the study eye within prior six months, or anticipated need for intraocular surgery within the next six months from the enrollment
  • Any major ocular pathology limiting potential vision such as large macular scars, vitreous hemorrhage, corneal opacities, visually significant cataracts, advanced glaucoma, or other types of optic neuropathy
  • Any history of Panretinal Photocoagulation (PRP) in the study eye or anticipated need for PRP within the next 6 months from enrollment
  • Any history of DME treatment (focal laser, anti-VEGF, or intraocular/periocular steroids) in the study eye in the past 4 months prior to the enrollment
  • Significant renal disease requiring dialysis
Show all 10Show fewer
  • Significant heart disease, stroke or transient ischemic attack requiring hospitalization in the past 4 months prior to the study
  • Presence of active ocular or periocular infection
  • Presence of active intraocular inflammation
  • Known hypersensitivity to aflibercept or to any ingredient in the formulation or to any component of the container

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Mississauga Retina Institute

    Mississauga, Ontario, L4X 2Z9

  • Toronto Retina Institute

    Toronto, Ontario, M3C 0G9

Other trials in Canada

About this study

The goal of this pilot study is to investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of centre-involved diabetic macular edema.

Read the detailed description

Diabetic macular edema (DME) is one of the major causes of visual decline among diabetic patients. Early Treatment of Diabetic Retinopathy Study has established focal/grid macular laser as the standard of treatment for clinically significant macular edema. More recently, intravitreal injections of anti-VEGF agents, either as monotherapy or in combination with focal/grid laser, have proven to be superior for the treatment of DME compared to laser alone.

Micropulse (MP) macular laser involves applying the laser in a fraction of the time within very small pockets of energy. Unline traditional focal/grid macular laser, the micropulse method of delivery does not leave any visible burns on the retina.

A recent release by the Diabetic Retinopathy Clinical Research Network has shown that deferring focal/grid laser and treating diabetic macular edema with only anti-VEGF may lead to better visual outcomes. Since MP laser does not have the undesired side effect of leaving laser scars on the macula, the study is to show that prompt MP laser in addition to anti-vegf injections may lead to better visual outcomes and/or decreased treatment burden without the undesired side effect of macular scarring.

Being tested
Micropulse Laser, Sham Laser
Keywords
DME, Micropulse Laser, Anti-VEGF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Micropulse LaserCombination product

    Aflibercept injection with Micropulse laser.

  • Sham LaserDevice

    Aflibercept injection with Sham Laser

Study groups in NCT03143192
Study groupRoleWhat they receive
Aflibercept with Micropulse LaserExperimentalAflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Micropulse Laser at initial visit and reassessed every 12 weeks.
Receives: Combination Product: Micropulse Laser
Aflibercept with Sham LaserSham comparatorAflibercept 2mg (0.05mL) injected intravitreally every 4 weeks or as needed Sham Laser at initial visit and reassessed every 12 weeks.
Receives: Device: Sham Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of injections for each group

    Number of intravitreal injections for each group

    Measured: 48 weeks

Secondary outcomes (11)

  1. Changes in visual acuity

    Changes in visual acuity from baseline to 24 adjusted for baseline

    Measured: 24 weeks

  2. Changes in visual acuity

    Changes in visual acuity from baseline to 48 weeks adjusted for baseline

    Measured: 48 weeks

  3. Changes in OCT Central Macular Thickness and Volume

    Measurement changes in central macular thickness at 24 weeks

    Measured: 24 weeks

  4. Changes in OCT Central Macular Thickness and Volume

    Measurement changes in central macular thickness at 48 weeks

    Measured: 48 weeks

  5. Number of injections half way

    Number of intravitreal injections of each group at 24 weeks

    Measured: 24 weeks

  6. Proportion of eyes with 2 or 3 lines of visual gain or loss

    Improvement or deterioration of vision of 2 or 3 lines at 24 weeks

    Measured: 24 weeks

  7. Proportion of eyes with 2 or 3 lines of visual gain or loss

    Improvement or deterioration of vision of 2 or 3 lines at 48 weeks

    Measured: 48 weeks

  8. Proportion of eyes that achieve 20/20 vision

    Eyes that are able to see 20/20 at 24 weeks regardless of baseline

    Measured: 24 weeks

  9. Proportion of eyes that achieve 20/20 vision

    Eyes that are able to see 20/20 at 48 weeks regardless of baseline

    Measured: 48 weeks

  10. Proportion of eyes that have PRP, vitreous hemorrhage, and vitrectomy.

    Proportion of eyes in each study group that require panretinal photocoagulation, have a vitreous hemorrhage, or require a vitrectomy during the course of the study.

    Measured: 48 weeks

  11. Proportion of eyes that had vision or OCT improvement

    In patients with HbA1c ≤ 8% or separately measured in patients with HbA1C > 8%

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2017
  2. Study start8 Mar 2017
  3. Primary completion9 May 2019
  4. Study completion9 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This will be a parallel study comparing the results of patients who receive aflibercept and micropulse laser versus those who only receive aflibercept. The second group will receive sham laser to prevent placebo effects.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03143192
Sponsor's protocol ID
19228
Acronym
DAM
Status last verified
Sep 2019
First submitted
1 May 2017
Last updated
10 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The results of this study will be analyzed statistically which will be shared with other members of the scientific community but the individual participant data along with their identifiers will not be available to other researchers.

Publications

  • Koushan K, Eshtiaghi A, Fung P, Berger AR, Chow DR. Treatment of Diabetic Macular Edema with Aflibercept and Micropulse Laser (DAM Study). Clin Ophthalmol. 2022 Apr 8;16:1109-1115. doi: 10.2147/OPTH.S360869. eCollection 2022.

    PubMed 35422607

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Micropulse Laser in people with Diabetic Macular Edema, run by Keyvan Koushan at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of injections for each group (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03143192, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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